8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT PURSUANT

TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported): October 20, 2008

AMAG PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware

(State or other jurisdiction of incorporation)

0-14732	04-2742593
(Commission File Number)	(IRS Employer Identification No.)
100 Hayden Ave
Lexington, Massachusetts	02421
(Address of principal executive offices)	(Zip Code)
(617) 498-3300
(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01 Regulation FD Disclosure

AMAG Pharmaceuticals, Inc. (the “Company”) today announced that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for ferumoxytol for the treatment of iron deficiency anemia in chronic kidney disease patients.

The Company submitted its New Drug Application for marketing approval of ferumoxytol in December 2007.

The Company believes that it can address the issues raised by the FDA in its complete response letter in a timely and expeditious manner without conducting any additional clinical trials prior to approval, including any clinical trials with respect to repeat courses of ferumoxytol or long-term follow-up of patients receiving ferumoxytol.  In addition, the Company continues preparations for the intended commercial launch of ferumoxytol during the first quarter of 2009. The Company continues to seek approval of ferumoxytol for the treatment of iron deficiency anemia in patients with chronic kidney disease, whether or not on dialysis.

The Company is continuing to evaluate the impact of the complete response letter on the timing of its other planned clinical development programs for ferumoxytol.

The full text of this press release is attached as Exhibit 99.1 hereto and is incorporated by reference herein.

Item 9.01.  Financial Statements and Exhibits.

(d)  Exhibits.

The Company hereby files the following exhibit:

99.1Press Release dated October 20, 2008.

2

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

AMAG PHARMACEUTICALS, INC.
By:	/s/ Joseph L. Farmer
	Joseph L. Farmer
	General Counsel and Senior Vice
	President of Legal Affairs
Date: October  20, 2008

3

EXHIBIT INDEX

Exhibit  Number	Description
99.1	Company Press Release Dated October 20, 2008

4

EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

Contact:

Kristen Galfetti

kgalfetti@amagpharma.com

(617) 498-3362

AMAG Pharmaceuticals Receives Complete Response Letter from FDA for Ferumoxytol

LEXINGTON, MA (October 20, 2008) – AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for ferumoxytol for the treatment of iron deficiency anemia in chronic kidney disease patients. The Company submitted its New Drug Application for marketing approval of ferumoxytol in December 2007.

The Company believes that it can address the issues raised by the FDA in its complete response letter in a timely manner without conducting any additional clinical trials prior to approval. In addition, the Company continues preparations for the intended commercial launch of ferumoxytol during the first quarter of 2009.

“We believe that we will be able to provide the information requested by the FDA in an expeditious manner,” stated Brian J.G. Pereira, President and Chief Executive Officer of AMAG Pharmaceuticals, Inc. “We will continue to work closely with the FDA and look forward to bringing ferumoxytol to market, which if approved, could provide a new treatment option for chronic kidney disease patients with iron deficiency anemia.”

About Ferumoxytol

Ferumoxytol, the Company’s key product candidate, is being developed for use as an intravenous iron replacement therapeutic agent for the treatment of iron deficiency anemia and as a diagnostic agent for vascular-enhanced magnetic resonance imaging to assess peripheral arterial disease.

About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its proprietary technology for the development and commercialization of therapeutic iron compounds to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease.

100 Hayden Avenue, Lexington, MA 02421
(617) 498-3300

-more-

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to, statements regarding the Company’s belief that it can address the issues raised and provide the information requested by the FDA in its complete response letter in a timely and expeditious manner and without conducting any additional clinical trials prior to approval, and statements regarding the Company’s continued preparations for the intended commercial launch of ferumoxytol during the first quarter of 2009, are forward looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward looking statements. Such risks and uncertainties include:  (1) The possibility that we may not be able to adequately address the issues raised and provide the information requested by the FDA in the ferumoxytol complete response letter and obtain the necessary regulatory approvals in order to market and sell ferumoxytol, or the possibility that we may not be able address such issues, provide such information or obtain such approvals in a timely manner, (2) the fact that we have limited sales and marketing expertise, (3) uncertainties regarding our ability to successfully compete in the intravenous iron replacement and imaging markets, (4) uncertainties regarding our ability to obtain favorable coverage, pricing and reimbursement for ferumoxytol, if approved, (5) uncertainties regarding our ability to manufacture ferumoxytol, (6) uncertainties relating to our patents and proprietary rights, and (7) other risks identified in our Securities and Exchange Commission filings, including our most recent Annual Report on Form 10-K.

We caution readers not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

###